Kornimate/medical-research-clean huggingface dataset:
study of ati-450 plus methotrexate (mtx) vs mtx alone in patients with moderate to severe ra

Conditions: Rheumatoid Arthritis

Summary: this is a phase 2 study to investigate the safety, tolerability, pk, and pd of ati-450 plus methotrexate versus methotrexate alone in patients with moderate to severe ra.

this is a phase 2, randomized, investigator and patient-blind, sponsor-unblinded, parallel group, placebo-controlled study to investigate the safety, tolerability, pk, and pd of ati-450 plus methotrexate versus methotrexate alone in patients with moderate to severe ra with inadequate response to methotrexate. all subjects will be required to complete a safety follow up visit 30 days post last study medication administration.

Eligibility criteria:
inclusion criteria: * diagnosis of adult-onset ra as defined by the 2010 american college of rheumatology/european league against rheumatism (acr/eular) classification criteria. * das28-crp ≥3.2 defined as moderate to high disease activity. * have moderately to severely active ra defined by at least 4/28 tender and 4/28 swollen joints. * hscrp ≥5 mg/l at screening. * patients must have definitive intra-articular synovitis or osteitis defined as a score of 1 or greater on a hand-wrist mri as assessed by central imaging reader (using ramris). * on a stable mtx dose and a stable dose of folic or folinic acid prior to the screening visit. exclusion criteria: * patient has a current acute or chronic immunoinflammatory disease other than ra which may impact the course or assessment of ra. * patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results. * history or evidence of active or latent tuberculosis. * active infection requiring treatment with antibiotics. * blood pressure levels (in supine position after at least 5 minutes rest): \ 140 mmhg for systolic blood pressure or \ 90 mmhg for diastolic blood pressure. * are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the screening visit. * have started treatment with non-steroidal anti-inflammatory drugs (nsaids) or have been receiving an unstable dosing regimen of nsaids within 2 weeks of the screening visit. * patients with history of stroke. * any joint procedure in the past 90 days prior to screening.

Keywords: arthritis rheumatoid
left bundle branch area pacing in avb patients

Conditions: Atrioventricular Block; Left Bundle Branch Area Pacing

Summary: right ventricular pacing (rvp) causes left ventricular mechanical dyssynchrony by inducing electrical interventricular and intraventricular dyssynchrony. his bundle pacing may restore the the atrioventricular, interventricular and intraventricular electrical synchronization, however, increased pacing threshold might result in the early depletion of the pacemaker, and finally brought on pacemaker replacement, which was one of the major causes of device infection. pacing the left bundle branch beyond the conduction block site might achieve a low and stable output and narrow qrsd. the investigators were prepared to consecutively include patients with atrioventricular block, divided into the left bundle branch area pacing(lbbap) group and the conventional right ventricular pacing group. the electrophysiological characteristics of lbbap and right ventricular pacing were compared with ecg characteristics. the left and right ventricular synchrony and left and right cardiac function were evaluated by 3d ultrasound, and the short-term and long-term safety and efficacy of lbbap were evaluated.

this study is intended to be included in fuwai hospital for admission to the atrioventricular block, with permanent pacemaker implant indications recommended by current guidelines. patients were assessed for preoperative electrocardiogram, quality of life scores, cardiac function, and left and right ventricular synchrony. patients were followed up by regular outpatients. the electrocardiogram, quality of life score, echocardiographic function, left and right ventricular synchrony, pacing parameters and pacing ratio were evaluated immediately after surgery, 3 months, 6 months, and 12 months after surgery. at the same time, the left bundle branch area pacing success rate, complications during intraoperative and postoperative follow-up were recorded.

Eligibility criteria:
inclusion criteria: 1. age over 18 years old; 2. atrioventricular block patients with indication for permanent ventricular pacing; 3. lvef\> 40%; 4. with informed consent signed exclusion criteria: 1. persistent atrial fibrillation; 2. moderate or more severe valvular disease; 3. hypertrophic cardiomyopathy； 4. myocardial amyloidosis； 5. with indication for crt or icd implantation according to the current guideline; 6. poor condition of the acoustic window because of emphysema or other reasons; 7. patients refused postoperative follow-up.

Keywords: atrioventricular block left bundle branch area pacing
histomolecular profiles of gliomas in children and adolescent/young adults

Conditions: Histological; Molecular Sequence Variation; Glioma

Summary: in the last decades, many advances have been made in the field of genetic abnormalities of glial and glioneuronal brain tumors. in the 2016 world health organization (who) classification of tumors of the central nervous system, the concept of "integrated" diagnosis emerged: histological and genetic/molecular features now define many entities. since 2016, six updates have been published by the c-impact-now (the consortium to inform molecular and practical approaches to cns tumor taxonomy- not official who) to develop and clarify the "integrated" diagnosis. in the future who 2021 classification of tumors of the central nervous system, "integrated" diagnoses will take up even more importance. even if they can have similar histological features, gliomas of children are very different from the "adult" gliomas in the molecular mechanism of oncogenesis. the histomolecular features of adolescents/young adults (ayas) can have similarities with "pediatric-type" or "adult-type" gliomas, but few studies have focused specifically on the histomolecular profiles of gliomas in ayas. the investigators would like to study the cohort of patients treated for a glial and glioneuronal tumor diagnosed under the age of 25 in the amiens university hospital between 2008 and 2020. the investigators would like to compare the histomolecular profiles of gliomas in children (0-14 years) and ayas (15-25 years).


Eligibility criteria:
inclusion criteria: * male or female patient * patient treated in the amiens university hospital * patient treated for a glial or glioneuronal brain tumor according to the 2016 who classification of tumors of the central nervous system ("diffuse oligodendroglia or astrocytoma tumour," "another astrocytic tumor," "another glioma" or a "mixed neuronal or glioneuronal tumour"). * diagnosis histologically confirmed or formally established by radiologist. * diagnosis established between january 1, 2008 and december 31, 2020. * no patient opposition (from adult patient, or from the holder of parental authority of the minor patient). exclusion criteria: * uncertain diagnosis * patient opposition (from adult patient, or from the holder of parental authority of the minor patient).

Keywords: histological molecular glioma adolescents/young adults children
ab-2004 in treatment of irritability associated with autism spectrum disorder (asd)

Conditions: Autism Spectrum Disorder (ASD)

Summary: the purpose of this study is to establish the potential benefits, safety, and tolerability of ab-2004 in participants with irritability associated with autism spectrum disorder.


Eligibility criteria:
key inclusion criteria: * clinically diagnosed, documented asd (diagnostic and statistical manual of mental disorders \[dsm-5\] criteria) * aberrant behavior checklist - irritability (abc-i) score ≥18 at the screening period * clinical global impression - severity (cgi-s) scale score ≥4 at the screening period key exclusion criteria: * use of an oral, injected, or inhaled antibiotic within 30 days prior to screening. prophylactic oral antibiotic use of no more than 1 dose will be permitted * current use of an oral controlled or extended-release medication * have a comorbid major psychiatric condition (eg, schizophrenia or bipolar disorder) at screening that in the opinion of the investigator may interfere with the subject's ability to complete study procedures/comply with study requirements * current use of antipsychotics (eg, aripiprazole or risperidone)

Keywords: irritability anxiety
udenafil therapy to improve symptomatology, exercise tolerance and hemodynamics in patients with chronic systolic heart failure

Conditions: Systolic Heart Failure

Summary: the purpose of this study is to determine if udenafil improves exercise tolerance in patients with systolic heart failure.

udenafil (zydena), a newly developed pde-5 inhibitor, has been proved to have similar efficacy and safety profile, compared with other pde-5 inhibitors. also, laboratory data showed that udenafil inhibits ventricular hypertrophy and fibrosis in rat heart failure model. based on these results, the investigators hypothesized that udenafil would improve symptom, exercise capacity and hemodynamic status in patients with systolic heart failure. in this 12-week, randomized, double-blind, placebo-controlled trial, patients with systolic heart failure will be enrolled according to the eligibility criteria. after randomization, study participants will be assigned to receive either 50mg of udenafil or placebo two times a day for 4 weeks, and then the dosage will be doubled to 100mg two times a day for next 8 weeks. participants will attend study visits at baseline and weeks 4 and 12. physical examination, medical history review, blood sample collection and electrocardiogram will be conducted on each study visits. at baseline and week 12, participants will undergo cardiopulmonary exercise test and exercise echocardiography. at every study visits,researchers will collect health information.

Eligibility criteria:
inclusion criteria: * ≥ 18 years of age, lv ef \< 40% exclusion criteria: * long-term use of medications that inhibit cytochrome p450 3a4. * inability patients with exercise test * primary pulmonary artery hypertension * severe hypotension (\ 170/100mmhg)

Keywords: systolic heart failure udenafil exercise capacity
anaesthetic efficacy of 2% mepivacaine versus 4% articaine with symptomatic irreversible pulpitis

Conditions: Symptomatic Irreversible Pulpitis

Summary: the aim of this randomized, double-blinded, clinical trial was to assess the effect of 3.6 ml 2% mepivacaine hydrochloride with 1:100,000 epinephrine compared to 3.4 ml 4% articaine hydrochloride with 1:100,000 epinephrine on the success of the inferior alveolar nerve block for patients with symptomatic irreversible pulpitis in mandibular molars.

the aim of this randomized, double-blinded, clinical trial was to assess the effect of 3.6 ml 2% mepivacaine hydrochloride with 1:100,000 epinephrine compared to 3.4 ml 4% articaine hydrochloride with 1:100,000 epinephrine on the success of the inferior alveolar nerve block for patients with symptomatic irreversible pulpitis in mandibular molars. patients were clinically and radiographically examined and their eligibility assessed and preoperative pain was measured using the numerical rating scale (nrs). patients were randomly assigned to one of 2 groups: experimental group (2% mepivacaine) and the control group (4% articaine). after 15 minutes of the inferior alveolar nerve block (ianb), patients reporting lip numbness had their molars accessed. no-to-mild pain response was considered success during root canal preparation.

Eligibility criteria:
inclusion criteria: * patients in good health (american society of anesthesiologists class i or ii). * patients having symptomatic irreversible pulpitis in one of their mandibular molars. * age range between 18 to 50 years. * patients who can understand numerical rating scale (nrs). * positive patient acceptance and the ability to sign an informed consent. exclusion criteria: * pregnant females. * patients allergic to articaine, mepivacaine and/or any used medication or material. * patients having active sites of pathosis in the area of injection. * patients having active pain in more than one molar. * patients who had taken analgesics in the 12 hours preceding treatment.
can postprandial reactive hypoglycaemia be reduced in patients after roux-en-y gastric bypass with a low carbohydrate diet?

Conditions: Bariatric Surgery (Gastric Bypass)

Summary: roux-en-y gastric bypass (rygb) accelerates nutrient delivery to the small intestine causing higher peak blood glucose concentration early after meal intake. in the late postprandial period (1 1⁄2-2 h) nadir blood glucose level is lower compared with before operation. in some patients, overt postprandial hypoglycaemia develops, and is typically reported as a complication 1-5 years postoperatively, when maximal weight loss has been obtained. the pathophysiology of postprandial hypoglycaemia involves inappropriate hyper-secretion of insulin associated with exaggerated secretion of the gut hormone glucagon-like peptide-1 (glp-1) leading to a mismatch between glucose absorption rate, insulin secretion and whole body glucose disposal. we hypothesize that lowering carbohydrate content of meals reduces postprandial glucose excursions whereby glp-1 and insulin secretion is reduced and reactive hypoglycemia prevented.


Eligibility criteria:
inclusion criteria: * rygb operated patients more than 12 month after operation * stable in weight for at least 3 months (+/- 3 kg) * plasma glucose below 3.4 mmol/l after screening with test meal (fresubin drink) or with continuous glucose monitoring exclusion criteria: * fasting plasma glucose concentration \> 7mmol/l * critical illness * hgb \< 6.5 mm * pregnancy or breastfeeding

Keywords: reactive hypoglycemia hyperinsulinaemia diet glucagon-like peptide-1 glucagon peptide yy ghrelin
prevalence of medical care in an emergency structure of the women victims of violence within the couple

Conditions: Spousal-Abuse

Summary: violence against women within the couple is a major socio-political and public health problem. indeed, in 2020, 219,000 women were victims of violence within their couple and 102 women were killed by their partner or ex-partner. on average, the number of women aged 18 to 75 who in the course of a year are victims of rape and/or attempted rape is estimated at 94,000 women, and in 47% of cases it is the spouse or the ex-spouse who is the author of the facts. this violence has major health and social consequences: the leading cause of death and disability among women aged 16 to 44 in europe. in france, a woman dies as a result of domestic violence every 2.5 days and the overall cost of domestic violence in 2012 amounted to 3.6 billion euros in france. a better knowledge of the use of care for wives of victims of violence and their feelings vis-à-vis the medical care in an emergency service will make it possible to identify the problems related to their care based on their feelings. of these patients, to understand why they would not have consulted as a first resort if necessary and to subsequently propose avenues for improvement.


Eligibility criteria:
inclusion criteria: * adult women (age ≥ 18 years old) * victims of violence committed within the couple * initial visit to the emergency room or not * subject not opposed to participating in the study exclusion criteria: * intra-family violence committed by a parent, outside the couple (for example: father, grandfather, brother, cousin, uncle, child) * impossibility of giving informed information to the subject (subject in an emergency situation, difficulties in understanding the subject, etc.)

Keywords: spousal-abuse violence against women
comparison of pudendal nerve block and caudal block for hypospadias in young children

Conditions: Hypospadias and Epispadias

Summary: the purpose of this randomized blinded prospective study is to compare the analgesic efficacy and duration of a pudendal nerve block (pnb) to a caudal block (cb) for pediatric patients, ages 6 months to 2 years, undergoing hypospadias repair.

hypospadias repair is one of the most common congenital malformations of the penis in the united states. it has an incidence of about 1 in 300 births. a combination of general anesthesia and a caudal block or general anesthesia combined with a pudendal nerve block are commonly used for hypospadias repair. in our institution, hypospadias repair is typically done in infants and children ages 6 months to age two. a comparison of the efficacy of pudendal block versus the caudal block has not been undertaken in this younger population.

Eligibility criteria:
inclusion criteria: * boys undergoing hypospadias repair exclusion criteria: -

Keywords: pudendal nerve block hypospadias caudal block
bxcl501 for agitation in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: agitation is characterized by excessive motor or verbal activity, irritability, uncooperativeness, threatening gestures, and, in some cases, aggressive or violent behavior. while agitation may have various underlying causes, patients with schizophrenia are especially vulnerable to acute episodes of agitation, especially during exacerbation of disease, and clinicians do not always diagnose these episodes early enough. agitation associated with psychosis is a frequent reason for emergency department visits, and unless it is recognized early and managed effectively, it can rapidly escalate to potentially dangerous behaviors, including physical violence. educating psychiatric professionals about the timely and accurate diagnosis of agitation among patients with schizophrenia or bipolar disorder and developing a well-tolerated easily administered medication will contribute to the prompt and effective management of this condition and could help reduce the risk of violent behavior and other undesirable outcomes. this study is designed to identify the ideal dose range and tolerability of sublingual dexmedetomidine in patients with schizophrenia.


Eligibility criteria:
inclusion criteria: 1. ability to give informed consent. 2. male or female between 18 and 65 years of age, inclusive 3. according to dsm-v meet criteria for schizophrenia or schizoaffective disorder. exclusion criteria: 1. current significant medical condition or other comorbidities 2. current substance dependence 3. women who are pregnant or breastfeeding
bovine lactoferrin versus ferrous sulphate in the treatment of iron deficiency anemia during pregnancy

Conditions: Anemia During Pregnancy

Summary: 130 pregnant women with iron deficiency anemia, in the 2nd trimester (microcytic hypochromic anemia, hemoglobin range from 9-10.5g/dl, serum ferritin less than 12 ng/ml), from the outpatient clinics in the obstetrics and gynecology department, in ain shams university hospital, cairo, egypt, will be enrolled and distributed into one of 2 groups by a computer generated random number table. each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. one group named l will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named f will receive ferrous sulphate tablet and placebo in powder form. hemoglobin concentration, packed-cell volume (pcv) , mean cell volume (mcv), mean corpuscular hemoglobin (mch), mean cell hemoglobin concentration (mchc), serum ferritin will be done at the start and the end of the treatment period.

the study will includes130 pregnant women, from the outpatient clinics in the obstetrics and gynecology department, in ain shams university hospital, cairo, egypt. women should be diagnosed as having iron deficiency anemia, in the 2nd trimester (complete blood count, showing microcytic hypochromic anemia, hemoglobin range from 9-10.5, serum ferritin less than 12 ng/ml). women will be enrolled and distributed into one of 2 groups by a computer generated random number table. each of the 2 groups will receive 2 medication for 2 months with specific instruction to increase iron absorption. one group named l will receive powders of bovine lactoferrin and tablets of placebo form, the 2nd named f will receive ferrous sulphate tablet and placebo in powder form. hemoglobin concentration, pcv, mcv, mch, mchc, serum ferritin will be done at the start and the end of the treatment period.

Eligibility criteria:
inclusion criteria: * pregnant with singleton intrauterine pregnancy * 14- 20 weeks of gestation * have iron deficiency anemia (ida) with hemoglobin 9 to less than 10.5 g/dl. exclusion criteria: * patients with a history of anemia due to any other causes such as chronic blood loss, hemolytic anemia, and thalassemia (including thalassemic trait). * hemoglobin less than 9 g/dl. * clinical and/or laboratory evidence of hepatic, renal, hematologic, cardiovascular abnormalities. * history of acid-peptic disorders, esophagitis, or hiatal hernia. * family history of thalassemia, sickle cell anemia, or malabsorption syndrome. * medical disorders with pregnancy. * bleeding in early pregnancy. * allergies to milk proteins / hypersensitivity to iron preparations. * history of ingestion of any hematinics within the last 1 month before study entry. * recent blood transfusion. * refusal to participate in the study.

Keywords: lactoferrin iron deficiency anemia in pregnancy
prevalence of visual dysfunction in neurological disorders

Conditions: Parkinson Disease; Other Neurological Disorders; Healthy

Summary: the objective is to determine the prevalence of visual dysfunction in people with parkinson's disease (pwp). the investigators will administer the: visual impairment in parkinson's disease screen and revised-self-report assessment of functional visual performance. patients seen at fixel institute and their caregivers will be invited to participate. responses to the 2 questionnaires will help determine prevalence rates of visual dysfunction in pwp compared to those both with and without other neurological conditions.

the purpose of this study is to identify the prevalence of visual dysfunction among persons with parkinson's disease, compared to other neurological conditions and controls without neurological conditions. data will be collected anonymously via redcap. patients seen at the fixel institute that have consented to be contacted regarding research opportunities will be recruited via blast email and advertisement in our institute's monthly newsletter, the movement messenger. the email and newsletter will contain a link for participation in surveys within redcap so the surveys can be completed anonymously at home. participation will be completely voluntary and responses will be recorded anonymously. data will include responses to the following: screening questions, the vipdq (visual impairment in pd questionnaire), and the r-srafvp (revised-self-report assessment of functional visual performance). the investigators will calculate the prevalence of visual impairment (from the vipdq) and dysfunction in performance of daily activities (from the r-srafvp) for pwp and compare this to the prevalence occurring in other neurological populations as well as the population without any neurological conditions. other data are collected so the investigators can then evaluate potential confounds or covariates. to ensure statistical methods are accurate, a statistician will be consulted.

Eligibility criteria:
inclusion criteria: * persons with parkinson's disease: confirmed diagnosis of parkinson's disease without presence of any other neurological condition. * persons without parkinson's disease (controls): no previous diagnosis of any neurological condition * persons with a single other neurological disorder (neuro controls): confirmed diagnosis of other neurological condition (e.g. als, multiple sclerosis, essential tremor, ataxia, etc). exclusion criteria: * children (ages younger than 18 years of age) * persons with more than one diagnosed neurological condition.